NCT03111225

Brief Summary

This study examines the prevalence of trigger points in muscles in the thorax in upper limb Complex Regional Pain Syndrome (CRPS) patients, compared to healthy subjects. In addition, we will examine if adding treatment to muscles in the thoracic area (to the regular physical therapy treatment) will alleviate some of the sensitivity in the upper limb in CRPS patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2017

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

April 7, 2017

Last Update Submit

September 5, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire

    Questionnaire that examines upper limb function

    10 minutes

Secondary Outcomes (7)

  • Goniometer

    1 minute

  • CRPS severity score (CSS)

    20 minutes

  • skin rolling test

    1 minute

  • trigger point examination

    5 minutes

  • NPRS

    1 minute

  • +2 more secondary outcomes

Study Arms (2)

CRPS patients

EXPERIMENTAL

CRPS patients that will be examined for trigger points in the thoracic muscles. 10 out of the 23 will also be included in the intervention stage and will recieve a month of conventional physiotherapy, and a month of conventional physiotherapy with addition of massage to the thoracic area.

Diagnostic Test: massage

healthy controls

NO INTERVENTION

healthy controls that will be examined for trigger points in the thoracic muscles (and will be compared to the CRPS patients)

Interventions

massageDIAGNOSTIC_TEST

a 15 minutes thoracic massage will be added to the regular physical therapy treatment

CRPS patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Tumors
  • Participation in another interventional clinical trial.
  • History of major psychiatric or neurological illness (like stroke).
  • Rheumatoid arthritis or other major rheumatologic disorders.
  • Fibromyalgia or any other systemic illness.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reuth Rehabilitation Hospital

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Study Officials

  • Jean-Jeaques Vatine, Prof

    Reuth Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The observation stage is a case- control study, the treatment stage is an A-B-A design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 7, 2017

First Posted

April 12, 2017

Study Start

June 6, 2016

Primary Completion

September 17, 2017

Study Completion

September 17, 2017

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations